Tuesday, February 21, 2012

Another Medical Industrial Outrage: Vital Drugs In Short Supply Because of Low Profit Margins

Well, here's a story that warms the heart. The chemotherapy drug methotrexate, which has been used to treat progressive forms of MS and is vital for the treatment of perilously ill juvenile leukemia patients, is in such short supply in the United States that cancer patients just might start dying due to its scarcity.

Is methotrexate some exotic new compound facing manufacturing difficulties due to the complexity of its chemistry? Does the shortage stem from a sudden rise in the population of patients suffering from a certain type of leukemia? Has the drug been found to be potentially harmful, or difficult to work with? The answer to all of these questions is no, and, shockingly, the underlying reason behind the shortfall of this essential medication is that manufacturing it simply does not generate enough profit.

Methotrexate is an old drug, first developed over 60 years ago. The patents that protected the original maker of the drug from competition expired decades ago. Therefore, the drug is now available only in generic form, and in a pharmaceutical universe where newer drugs can fetch over $100,000 per patient per year, methotrexate costs only a few bucks per dose. When used to treat patients suffering from Acute Lymphoblastic Leukemia, a particularly virulent form of the leukemia which typically strikes children from 2 to 5 years old, the drug can cure over 90% of the estimated 3500 juveniles diagnosed with the disease in the US each year. Great, right? A cheap, effective drug that successfully treats a horrible illness that kills children, what better example could there be of the triumph of modern medicine? Well, not so fast. Turns out the saga of methotrexate and other generic medications also suffering shortages are a shining example of a plague that infects the medical industrial complex that has evolved in this country over the last several decades: flat out greed.

As has been widely reported (click here), supplies of methotrexate are within weeks of running out. Apparently, one of the four factories manufacturing the drug was shut down because of "significant manufacturing and quality concerns", according to the company that runs the plant, Ben Venue Laboratories. Another article (click here) states it much more graphically. An expert on drug shortages explains that the FDA found "mold on the walls and rust from machinery falling into the vials. It really provides a very grim picture of a crumbling factory." Not exactly the image you want to have in mind the next time you reach for that bottle of generics in your medicine cabinet, but apparently factories manufacturing such drugs are the sweatshops of the pharmaceutical industry.

The shortage of methotrexate is far from an aberration. Methotrexate is one of 287 drugs that have been in short supply this year, up from 61 in 2005 (click here). The vast majority of these drugs are cancer medications, and although some of the shortages can be attributed to a scarcity of the raw materials required to make them, the bulk of the problem resides in the fact that many of these drugs are generic, and don't generate much profit for the companies that manufacture them, or the doctors who prescribe them.

Unlike most patients, who by their drugs from pharmacies, cancer patients often purchase their chemotherapy drugs directly from their oncologists, a system that developed decades ago, when only oncologists would handle the toxic materials and the drugs were relatively cheap (click here). Some oncologists rely on drug sales for half of their yearly revenue. These days, Medicare reimburses oncologists 6% above the wholesale cost of the drug, giving the physicians ample reason to prescribe newer, brand-name drugs (more expensive, more profit) rather than older generic drugs (less expensive, less profit). In turn, the demand for lower-cost generics has been driven down, making their production a low profit venture.

Problems arise when there are no newer, more expensive substitutes for the generic drugs, as is the case with methotrexate and the treatment of Acute Lymphoblastic Leukemia. To make matters worse, drug manufacturers are currently not required to inform the Food and Drug Administration when supplies start to run short, so the FDA might have opportunity to ask other makers to ramp up production before the drugs in question run out, as happened earlier this year with Doxil, a compound used to treat ovarian cancer. A bill introduced in the U.S. Senate in this month would require drug manufacturers to alert the FDA of any pending shortages, or if they were ceasing production of a drug. The FDA, though, has no enforcement authority in these matters, and can't dictate the manufacture of drugs in short supply. In the case of Doxil, which was in dangerously short supply for about eight months, the FDA recently worked out a deal with an Indian pharmaceutical manufacturer to supply the US with a replacement drug.

Clearly, the system is seriously broken. It would be bad enough if we were talking about over-the-counter cold remedies, but the drugs in question save lives every day, or at least every day that they are available. Our system of medicine is rotting from the inside out due to the corrosive siren song of hugely profitable blockbuster medications and dizzyingly expensive treatment protocols, which admittedly can be of great benefit to some patients, but have fundamentally changed the way medicine is researched and practiced in the USA. The Europeans have handled the similar situations by mandating higher prices for generics, thereby making them more profitable. Brand-name drugs are generally cheaper in Europe as well, and as a result European countries have not experienced shortages of these same cancer drugs. For better or worse, the US has no such mechanism to dictate prices, and there is no easy fix to the problem. One has only to imagine the agony of a parent watching their child die for lack of a medication to understand at a guttural level the huge import of this problem. What a god-awful mess…

13 comments:

Wow...I have a 5 yr old and god forbid I would ever have to live in a nightmare situation like this. I truly do hate the amount of greed and corruption that goes on this country. It is sickening. Of course, the rich would buy it elsewhere, where as the rest of us(I'm considered middle class just in case you wanted to label me) would be forced to bow to the system. Thanks Marc, for bringing to light this terrible situation. Sharing to Facebook...

It is terrible that medicine has devolved into treating patients as customers, figures on a tally sheet. What isn't as easily accountable is the price in human suffering, I'm not sure there's a way to balance those books…

It is such a shame that something that can CURE & is relatively inexpensive is in such short supply. We've been through the cancer route with our daughter when she was 13--she had a brain tumor, so we know very much how stressful it can be & we didn't have any shortages of medication to deal with. On the other hand of the spectrum, I just started taking Gilenya thursday. I also just received an EOB & the cost for a 30 day supply of Gilenya is $12,157.44! That is ludicrious.... it won't even "cure" me. What ever happened to trying to say patients lives? KIM

So sorry to hear of your daughter's illness, I hope she's now doing well…

Unfortunately, curing is not as lucrative as treating. Our medical research apparatus has been hijacked by the pharmaceutical companies, who fund more and more of the research. 30 years ago most of the research was done in academic environments, now it's done in commercial labs. Researchers have to eat, so they flock to him where the money is, and unfortunately research projects that don't hold the promise of developing into blockbuster treatments/Medications don't get very far…

I love all your postings and I I find that today I am especially relishing this one in the "rant" category. So there is more to the drug manufacturer story than greed, eh?

I'd like to know more about the companies that manufacture the low-cost generics. Who are they? What kind of profits do they see? Why did they chose this business? Hard to believe someone who is making billions has rusty things around.

I think there is a lot of money to be made in generics, as long as the demand is there. Unfortunately, most medications are used for a variety of illnesses, and if it just so happens that a generic is the only drug available for that illness, and it has fallen out of favor in treating other diseases, people with that lone illness are between a rock and a hard place.

I too wonder about the companies that manufacture generics. I've seen it said repeatedly that the generics are chemically equivalent to the brand-name drugs in every way, but I know for a fact that if I get the generic version of one of the medications I'm on things go kablooey…

I think if a lot of MS patients got their legs back there would be many asses being kicked. I've got quite a few doctors on my list that would need to be wearing pants with padded backsides for a while…

To Ease Shortage, F.D.A. Lets 2 Cancer Drugs Be Imported"The two drugs are Doxil and methotrexate, and in both cases supplies in the United States are being bolstered by shipments from abroad. Shortages of scores of other drugs continue." Lipodox (similar to Doxil) is being imported from India and methotrexate from Australia.

But the issue isn't just that there's no money in it for drug companies to produce the generics, but also "there is a years-long backlog of applications for new generic drugs at the F.D.A. because the government does not have the money to hire enough reviewers to analyze the applications or inspectors to visit the facilities, many of them abroad. The generic drug industry tired of waiting for Congress to fully finance the F.D.A.’s generic drug office and this year proposed providing the agency with $299 million in annual fees to finance the review process."

From what I've read, Europe has not experienced these kinds of drug shortages due to the fact that most European governments can dictate higher prices on generics, and in general the newer drugs are priced lower than they are here in the US. Therefore, the forces of supply and demand are limited, keeping the generic drugs in the game…

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Regretfully, due to the high volume of e-mail received and the realities of living with progressive MS, I'll no longer be able to respond to all e-mails sent. I do read each note, and will do my best to answer as many messages as I can.

About Me

I'm Marc, a 53-year-old male, living in New York City with my lovely and wonderful wife Karen. Diagnosed with Primary Progressive Multiple Sclerosis in March of 2003, I now require a wheelchair to get around the city. I like to drive the wheelchair at full speed, thus the moniker "Wheelchair Kamikaze". I've managed to rig a camera to my chair, so I'm able to take videos and still photos from the unique vantage point of a wheelchair, which I intend to post here.
Before getting sick, I was the Director of DVD Production for one of the major international music companies. Yes, I was once a member of the Evil Empire...
Prior to my enlistment in the Evil Empire, I worked as a video producer and editor.
I grew up in New York City, and spent the 1980s in Boston (college and postcollege rock 'n roll craziness). During the 1990s, I lived in South Florida, until I woke up one morning and realized I was living in South Florida, came to my senses, and moved back to New York.
I hope you like my blog...